| Title | Winter | Spring | Summer | Fall |
| Required Courses - Pharma Track |
Introduction to Regulatory Affairs and Compliance for Drugs, Biologics, and Medical Devices (2.00 Units)
PHRMSCI X480
This course presents an introduction to the field of regulatory affairs and to the laws and regulations governing healthcare products, including drugs, biologics, dietary supplements, and medical devices. Individuals from various disciplines who are new to the field of regulatory affairs will explore the regulatory pathways for each of these medical products and learn how to maintain regulatory compliance with U.S. regulations throughout the product lifecycle. Examine the structure of the FDA and the historical context of current FDA regulations governing healthcare products. Appreciate the complexities of global regulatory affairs through an introduction to the regulatory structure in the European Union. This course provides an introduction to the regulatory affairs profession and provides a framework for subsequent courses in the Regulatory Affairs and Compliance Certificate Program.
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to be scheduled
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Online
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Regulatory Requirements for Pharmaceutical Products (3.00 Units)
EECS X445.26
This course presents a detailed overview of the regulatory requirements for the discovery, development, and commercialization of pharmaceutical products (drugs and biologics). Individuals involved in manufacturing, quality control, research and development, and clinical studies will learn the latest information. Explore topics that include the product development process through commercialization, product characterization and pre-clinical evaluation, pharmaceutical industry requirements, clinical trial requirements, good manufacturing practices (GMPs), good laboratory practices (GLPs) and inspections, labeling medical products and writing Food and Drug Administration (FDA) submissions.
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to be scheduled
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to be scheduled
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Online
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Fundamentals of Clinical Trials (3.00 Units)
BIO SCI X450
Clinical trials are designed to answer questions concerning the safety and effectiveness of medical products. Get an overview of clinical trials regulated by the FDA. Learn about the planning process underlying the Strategic Clinical Plan and regulatory submissions to the FDA. Explore topics including protocol development and implementation, i.e., study site selection, financial controls, timelines, and management of the site's operations; proper informed consent; Good Clinical Practices compliance; HIPAA; FDA regulations and guidelines; and post-market support studies.
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Online
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to be scheduled
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Post-Approval Compliance Requirements for Pharmaceutical Products (2.00 Units)
PHRMSCI X481
Product approval is a crucial milestone in a product’s lifecycle, after which, the marketing phase begins and post-approval compliance requirements commence. This course explores the FDA regulatory requirements for drugs and biologics following product approval. Some of the areas covered include promotional labeling and advertising, post-marketing surveillance (e.g., adverse events, recalls), post-marketing commitments, post-approval manufacturing changes, post-approval submissions to the NDA/BLA, supply chain management, and quality systems, including compliance with 21 CFR 11 governing electronic records. Students who complete this course will be equipped with relevant knowledge and skills needed to meet post-approval regulatory requirements.
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Online
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to be scheduled
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| Required Courses - Device Track |
Introduction to Regulatory Affairs and Compliance for Drugs, Biologics, and Medical Devices (2.00 Units)
PHRMSCI X480
This course presents an introduction to the field of regulatory affairs and to the laws and regulations governing healthcare products, including drugs, biologics, dietary supplements, and medical devices. Individuals from various disciplines who are new to the field of regulatory affairs will explore the regulatory pathways for each of these medical products and learn how to maintain regulatory compliance with U.S. regulations throughout the product lifecycle. Examine the structure of the FDA and the historical context of current FDA regulations governing healthcare products. Appreciate the complexities of global regulatory affairs through an introduction to the regulatory structure in the European Union. This course provides an introduction to the regulatory affairs profession and provides a framework for subsequent courses in the Regulatory Affairs and Compliance Certificate Program.
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to be scheduled
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Online
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Regulatory Requirements for Medical Devices (3.00 Units)
EECS X445.2
Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing premarket notification 510(k), and planning and submitting a Pre-market approval (PMA). Gain knowledge on CE mark according to European Medical Device Regulations 2017/745 (EU-MDR), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. Get a review of device registrations in Canada, Australia, Japan, China and Latin America. Also, enhance your knowledge of related regulatory topics that include: global vigilance requirements and labeling requirements.
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to be scheduled
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Online
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Regulatory Affairs for Post-Market Approval (2.00 Units)
BME X413.2
Learn how to continuously evaluate and perform periodic reporting on the safety, effectiveness, and reliability of a medical device for its intended use. Utilizing design controls practices and procedures, participants learn "design transfer" from research and development to manufacturing. Increase your knowledge on managing regulatory affairs activities for engineering design modifications, post approval studies, and after market product changes. Participants learn how to recognize the regulatory pathway for changes in labeling, manufacturing process, design, sterilization, packaging, material and vendor; changes due to customer complaints, product recall or field corrective action.
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to be scheduled
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Regulatory Affairs Planning and Management (3.00 Units)
BME X412
Learn how to organize your medical product design teams to meet the stringent FDA requirements and Regulatory Affairs. This course has two phases, concept review and evaluation review that provides a baseline knowledge on the role of regulatory affairs professional. Participants learn how to guide medical product designers through the design and development stages based on product classification to demonstrate safety and efficacy or performance for human use; and regulatory approval. Participants will be guided on how to conduct pre-submission meetings with the FDA, how to request meetings with the FDA, prepare and send pre-IDE packets, and how to record and document meetings with the FDA.
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Online
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| Elective Courses (5 units) |
Drug Safety and Pharmacovigilance (2.00 Units)
PHRMSCI X493
With increasing public and regulator focus on product and patient safety, regulatory requirements in this area have become more demanding. Regulatory Affairs professionals work closely with the pharmacovigilance team to comply with regulatory authority requirements and ensure product safety. Learn the essential elements of pharmacovigilance and managing risks/benefits of drugs and biologics throughout the product lifecycle. With focus on US and EU requirements and international harmonization guidelines, explore topics that include pre-marketing and postmarketing adverse event surveillance and reporting, individual case safety reports, aggregate safety reports, safety operational units, MedDRA coding, quality systems, good pharmacovigilance practices, safety inspections, electronic records, safety labeling, signal detection, risk management (REMS, RMPs), and pharmacoepidemiology.
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Online
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Medical Device Quality Systems (3.00 Units)
MGMT X442.6
Learn about the essential elements of Quality System Regulations (QSR's) and Good Manufacturing Practices (GMP's), how there is a commonality between them, and how to develop a global approach to Quality Systems in order to satisfy international requirements of ISO 13485:2016. A detailed analysis of these systems and practical 'how to' recommendations and approaches are presented, with particular emphasis on the United States Food and Drug Administration (FDA) QSR's and GMP's.
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Online
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to be scheduled
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Medical Device Marketing (3.00 Units)
MGMT X445
Getting your medical product to market successfully starts before product design and does not end with the product launch. This course focuses on the special considerations needed to successfully market products within medical devices and related industries. Learn how to analyze the market and what information medical marketers must maintain to make smart product decisions throughout the product development process. Understand the idiosyncrasies of the medical marketing environment and its impact on strategic and tactical marketing decisions. Gain the knowledge you need to identify and understand customers and in medical markets and provide them with value through innovation, sales and service. Case studies and insights from practicing medical product professionals enhance the application of classroom concepts.
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to be scheduled
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Online
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Overview of Global Regulatory Affairs (3.00 Units)
PHRMSCI X490
With the expansion of global markets in the pharmaceutical industry, regulatory affairs professionals must be well-versed in multinational regulatory requirements. This course presents an overview of the regulatory agencies and regulations for drugs and biologics, in the European Union, Canada, Japan, and other major markets in comparison with the U.S. regulatory system. The course will explore topics that include international harmonization efforts, premarket regulations, authorization requirements, and regulatory agency enforcement. Students will learn how to apply knowledge of international regulations to formulate a global regulatory strategy for product development.
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Online
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Medical Device Life-Cycle Management (3.00 Units)
BME X408
From concept through development to approval, the Medical Device Life Cycle integrates design, development, validation, and commercialization. Further your understanding of the phases, requirements, and deliverables of the Device Life Cycle in order to manage projects and multifunctional teams. Topics covered include Product Development Process, Customer Requirements, Proof of Concept, Design Control, Design Verification and Validation, Design Transfer, Product Launch, Risk Management, regulatory strategy, intellectual property management, project management, start-up company experiences, and time to market.
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to be scheduled
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Online
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